US5376114A - Cannula pumps for temporary cardiac support and methods of their application and use - Google Patents

Cannula pumps for temporary cardiac support and methods of their application and use Download PDF

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Publication number
US5376114A
US5376114A US08/015,246 US1524693A US5376114A US 5376114 A US5376114 A US 5376114A US 1524693 A US1524693 A US 1524693A US 5376114 A US5376114 A US 5376114A
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Prior art keywords
pump
blood
cannula
motor
heart
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US08/015,246
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English (en)
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Robert Jarvik
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Individual
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Individual
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Priority to US08/015,246 priority Critical patent/US5376114A/en
Priority to PCT/US1993/009947 priority patent/WO1994009835A1/fr
Priority to AU53635/94A priority patent/AU678411B2/en
Priority to CA002147616A priority patent/CA2147616C/fr
Priority to JP6511123A priority patent/JPH08504621A/ja
Priority to EP93923927A priority patent/EP0746344A4/fr
Priority to US08/325,848 priority patent/US5776190A/en
Priority to US08/334,498 priority patent/US5755784A/en
Application granted granted Critical
Publication of US5376114A publication Critical patent/US5376114A/en
Priority to AU17703/95A priority patent/AU683994B2/en
Priority to AU17704/95A priority patent/AU678697B2/en
Priority to US08/974,019 priority patent/US5888241A/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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    • A61M60/40Details relating to driving
    • A61M60/403Details relating to driving for non-positive displacement blood pumps
    • A61M60/408Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
    • A61M60/411Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
    • A61M60/414Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
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    • A61M60/165Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
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    • A61M60/17Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
    • A61M60/174Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
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    • A61M60/178Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
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    • A61M60/178Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
    • A61M60/183Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices drawing blood from both ventricles, e.g. bi-ventricular assist devices [BiVAD]
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    • A61M60/216Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
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    • A61M60/30Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/36Medical purposes thereof other than the enhancement of the cardiac output for specific blood treatment; for specific therapy
    • A61M60/38Blood oxygenation
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    • A61M60/523Regulation using real-time patient data using blood flow data, e.g. from blood flow transducers
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    • A61M60/531Regulation using real-time patient data using blood pressure data, e.g. from blood pressure sensors
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    • A61M60/50Details relating to control
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    • A61M60/538Regulation using real-time blood pump operational parameter data, e.g. motor current
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    • A61M60/818Bearings
    • A61M60/824Hydrodynamic or fluid film bearings
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    • A61M60/802Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/818Bearings
    • A61M60/825Contact bearings, e.g. ball-and-cup or pivot bearings
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    • A61M60/861Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
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    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • A61M2205/3334Measuring or controlling the flow rate
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    • A61M60/126Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/148Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices

Definitions

  • This invention relates to circulatory support utilizing miniature rotary blood pumps inserted into the heart for emergency use or during heart surgery.
  • the invention includes pumps mounted within cannulae adapted for extremely simple application at surgery which are capable of providing the entire pumping output required for patient survival.
  • Mechanical blood pumps are commonly applied to temporarily support the pumping function of the heart during heart surgery or during periods of heart failure.
  • the most widely applied devices include roller pumps and centrifugal pumps currently used in more than 400,000 cases of heart surgery annually.
  • the pumps comprise part of a cardiopulmonary bypass circuit in which many components are combined including an oxygenator, a heat exchanger, blood reservoirs and filters, and many feet of tubing to transport the blood from the patient on the operating table to the heart-lung machine located nearby and back to the patient.
  • Blood is withdrawn from the patient via uptake cannulae placed into the vena cavae and atria or ventricles of the heart and pumped back into the pulmonary artery and aorta via return cannulae.
  • the system generally works well but is complicated and expensive, exposes the blood to a high surface area of foreign materials which causes damage, requires full anticoagulation, and requires considerable time to set up and manage by a skilled technician.
  • the heart In most cases of coronary artery bypass surgery the heart is cooled and stopped and an oxygenator is used although it is not necessary to actually open the heart as it is with valve surgery. In a few cases, the oxygenator is omitted from the system and the patients own lungs continue to function during the course of the surgical procedure. In such cases, either the pumping function of the left ventricle alone or both the left and right ventricles, is supported mechanically. Pulsatile pumps and continuous flow pumps have been used experimentally and in human cases. The heart is not cooled and is not stopped, although drugs may be given to slow its rate.
  • the procedure has a number of important advantages in appropriate cases, however, present blood pumps, cannulae, and tubing sets have not been developed specifically for this application, and setup, cannulation, priming, and patient management during the procedure are somewhat makeshift and leave room for considerable improvement.
  • the cannula pump of the present invention is especially suited to this use, and greatly simplifies the procedure, reducing the number of cannulation sites, reducing the surface area of foreign materials, reducing the priming volume and setup time, and permitting very simple management of heart function during the procedure.
  • a single cannula containing a miniature rotary pump is inserted into the heart, via a small incision, and both the necessary inflow and outflow connections are accomplished immediately.
  • the blood pump may be inserted via the apex of the ventricle, the atrium, or the aorta, but in each case only one cannulation is necessary.
  • the pump itself resides within the cannula and is connected by a short drive shaft to a small motor outside the heart, usually positioned immediately adjacent to the heart in direct connection with the cannula. If support of the pulmonic circulation is required, this is also achieved by a single cannulation via the right ventricle, right atrium, superior vena cava, or pulmonary artery.
  • two cannula pumps each requiring only one cannulation site, are used.
  • Cannula pumps are advantageous in cases requiring emergency circulatory support where the chest can be rapidly opened for access to the heart and the simple cannula pump can be inserted immediately. Because no cumbersome or large equipment is involved, the device can be applied in tight quarters, where use of larger more complicated systems is precluded, and in cases of cardiac arrest where there is inadequate time to setup and prime other devices. Examples include ambulance, aircraft, emergency room, cardiac cath lab, and rescue or military use in the field.
  • the present invention relates to miniature blood pumps utilized to provide all or part of the pumping function of the heart during cardiac surgery, during temporary periods of heart failure, and during medical emergencies involving severe heart failure.
  • the device includes a miniature pump, such as an axial-flow or mixed-flow pump mounted within a generally tubular cannula, similar in size and shape to cannulae used to withdraw blood from the heart or to return blood to the great vessels during routine heart-lung machine utilization.
  • the cannulae generally differ functionally because, with the pump mounted within the cannula, a single cannula is able to provide both the inflow and outflow functions and therefore a single insertion site is sufficient, in many cases.
  • two cannulation sites may be used.
  • the pumps of the present invention may use blood-immersed mechanical bearings and the principles of high-flow washing of the junction of the rotary and stationary parts of the pump to prevent thrombus accumulation. These principles together with the method of intraventricular implantation are disclosed in my previous patents U.S. Pat Nos. 4,994,078 and 5,092,879. Although the present invention has much in common with the inventions of these prior patents, basic adaptations of the pump and motor bearing system are new as well as the cannula type of device, its function, and its methods of use.
  • the present invention utilizes a small-diameter wire as a rotating shaft which drives the pump impeller, compared to the stationary wire of the previous devices. It is feasible for temporary use since wear is minimal in a period of a few hours or even a few weeks, compared to the permanent implant applications which require durability of many years. Tension on the wire is not required, and the wire is sufficiently stiff to impart the necessary rotary torque without warping, breaking, or vibrating excessively.
  • the pumps are smooth and quiet during use and will not cause significant blood damage if fabricated properly.
  • the present invention requires major surgery for its insertion and differs from previous prior art inventions such as the "HIGH-CAPACITY INTRAVASCULAR BLOOD PUMP UTILIZING PERCUTANEOUS ACCESS" by Wampler, U.S. Pat. No. 4,625,712, in its structure and function, as well as its intended use.
  • the present cannula pump is not suitable for percutaneous access, and is inserted via major surgery for use during the surgical procedure, or for relatively short term use following surgery.
  • the invention of Wampler utilizes a remote motor placed about a meter away from the pump and connected to it via a long flexible shaft.
  • the motor is located outside the body whereas the motor used with the present invention is implanted within the body and is directly coupled to the pump by a short stiff shaft only a few centimeters long. This eliminates the problem of flexible shaft breakage which has caused the FDA to withdraw experimental approval to test the Wampler pump in human patients. Since the present pump is not inserted through a long small diameter blood vessel via an access site remote from the heart, it is able to be large enough to support the entire cardiac output, as roller pumps and centrifugal pumps utilized during cardiac surgery typically must do. The Wampler pump is limited due to the small diameter mandated by the remote insertion requirement and can only provide a fraction of the blood flow necessary for full support of the patient. Essentially the Wampler pump is a remotely inserted assist pump, and the present invention is a directly inserted, high flow, total cardiac output bypass pump.
  • cannula pumps of the present invention approximately 1.2 cm in diameter, blood flow up to 8 liters per minute is obtained with 100 mm-Hg outflow pressure and rotational speed varying from approximately 15,000 to 25,000 rpm, depending upon flow and pressure. With flow in the range of 6 liters per minute and pressure in the range of 80 mm-Hg, which represents a typical operating condition, the power requirement for the system is below 15 watts. This permits battery operation for several hours with a very compact and lightweight battery.
  • the system may include a simple control and display module which is small enough to be sterilized and utilized in the sterile surgical field. It may also incorporate microprocessor-based control and monitoring algorithms to regulate the flow and pressure, or to display the flow and pressure measured by sensors or calculated from comparison of measurements of speed and power consumption to a known database.
  • Cannulae may be provided with built-in pressure sensors or flow-sensing devices such as a hot-wire anemometer or ultrasonic flow probe, and may be configured such that the simple insertion of the cannulae accomplishes complete instrumentation including pressure and flow measurements at the appropriate locations.
  • the cannula pumps may be used with no flow and pressure sensors and patient management can be accomplished by other observations, such as the degree of expansion or collapse of the left atrium during surgery and the adequacy of perfusion as judged by the arterial blood gases.
  • the cannulae pumps are capable of being fabricated utilizing primarily injection-molded, polymeric components, permitting low-cost and disposability of the cannulae and pumps themselves.
  • the motors which provide rotary power to the shaft may be provided in a reusable configuration or also maybe made very inexpensively to permit them to be disposable.
  • a completely disposable unit incorporating both a disposable motor and pump together with the cannulae is disclosed as one embodiment of the invention.
  • FIG. 1 is a schematic illustration of the heart, partially in section with the anterior wall of the right ventricle and part of the pulmonary artery removed.
  • Two cannula pumps are shown, one inserted through the apex of the left ventricle, with the out-flow across the aortic valve into the aorta and the other inserted across the apex of the right ventricle with the outflow across the pulmonic valve into the pulmonary artery.
  • FIG. 2 shows a longitudinal section of a cannula pump including the motor module. The pump and motor are assembled for use.
  • FIG. 3 is a longitudinal section of the generally cylindrical cannula and blood-pumping components contained therein.
  • FIG. 3 is an enlarged portion of the cannula pump system illustrated in FIG. 2.
  • FIG. 4 is a longitudinal section of a reusable motor and motor housing. The disposable components of the cannula pump are not shown.
  • FIG. 5 is a longitudinal section of the disposable components the cannula pump illustrated in FIG. 2, showing all disposable components with the exception the outflow cannula and including a removable hypodermic needle for filling a fluid chamber within the device.
  • FIG. 6 is a longitudinal section of a cannula pump having a disposable motor disposed in a housing formed integral with the cannula.
  • FIG. 7 is a longitudinal section of another embodiment of a cannula pump showing a reusable motor and motor housing, and a disposable pump with the cannula in position to be coupled to the rotating shaft of the motor via a mechanical connector.
  • FIG. 8 is a longitudinal section of an embodiment of the invention in which a small diameter motor having an outside diameter approximately the same as the largest diameter of the pump is incorporated within the cannula.
  • FIG. 9 is a schematic drawing of the heart and great vessels in which a cannula pump similar to that shown in FIG. 8 has been inserted into the left ventricle with the outflow cannula section placed across the aortic valve into the aorta.
  • FIG. 10 is a schematic drawing of the heart showing a cannula pump placed with the electric motor in the right atrium, and the pump placed within the right ventricle, with the outflow cannula section positioned across the pulmonic valve into the pulmonary artery.
  • FIG. 11 is another schematic illustration showing the left ventricle and aorta, with the right ventricle removed.
  • a cannula pump is shown placed with the motor within the left ventricle and the pump together with the outflow cannula section placed in the aorta.
  • a tube generally known as a cannula
  • Cannulae of many sizes and shapes are used, including flexible polymer tubes, wire-reinforced polymer tubes, and even rigid metal tubes.
  • these tubes must be small enough to permit them to be inserted into the heart or great vessels with minimal damage to the tissues and must be large enough to permit sufficient blood flow given that a considerable pressure drop occurs across small diameter tubes at higher flow rates, especially when the tubes are long.
  • the present invention provides pumps mounted inside the cannulae themselves which has many advantages previously cited, including greater simplicity of application to the patient, reduction in the resistance to blood flow of long tubes, reduced exposure to foreign materials, and ease of patient management.
  • Cannula pumps may be provided in numerous embodiments., may reside within the heart itself, within the great vessels, or only a portion of the cannula may be introduced into the vascular system and the pump may be located outside the heart and beside it on the surgical field.
  • FIG. 1 is a generally schematic view of the heart showing two cannula pumps inserted for support of both the left heart function and the right heart function.
  • the left ventricle, generally indicated at 2 contains a miniature axial flow pump within a cannula
  • the right ventricle, indicated at 4 contains another pump.
  • the outflow portions of the cannulae deliver blood respectively from the left ventricle 2 into the aorta 6, and from the right ventricle 4 into the pulmonary artery 8.
  • the cannula pump in the right ventricle is driven by an electric motor, generally located and shown at 10.
  • the actual axial flow blood pumping portion is indicated at 12, and the outflow tube which channels the blood into the pulmonary artery is shown at 14.
  • a second cannula pump inserted in the left ventricle, is powered by an electric motor 16, and contains an axial flow pump within the left ventricle 18 into which blood enters through side holes 22 as indicated by the arrows.
  • the blood is pumped out of the outflow portion of the cannula 20 which carries the blood across the aortic valve leaflets 24 and into the aorta 6.
  • the right and left cannula pumps together thus intake blood from both ventricles and pump the blood into the two main arteries leaving the heart.
  • the pump is respectively inserted through a small incision in the apex of either ventricle and held there by a purse-string suture as indicated in FIG.
  • the outflow valve that is the aortic valve or pulmonary artery valve
  • the outflow valve is able to close around the outside of the cannula permitting a sufficient seal to prevent major leakage back from the artery into the respective ventricle.
  • This increases the effectiveness and efficiency of the pump because if the valve were absent or incompetent, a considerable portion of the blood ejected out of the cannula could flow directly back to the inflow side of the pump effectively making a short circuit without being pumped through the organs of the body as desired.
  • cannula pumps may be used where the inflow into the pump is via the apex of the ventricle or via the atrium and the outflow of the pump returns the blood into the aorta or pulmonary artery via a second incision into that blood vessel.
  • cannula pumps that withdraw blood from the atria and return it to aorta or pulmonary artery, are required rather than devices inserted into the ventricular cavity.
  • FIG. 2 shows a longitudinal sectional view of the cannula pump.
  • Blood enters the axial flow pump section 18 through side holes 22, and is ejected through the outflow cannula 20.
  • the pump contains a rigid, relatively elongated portion 32 which is passed across the apex of the heart and serves as a support around which the heart muscle is tied utilizing the purse-string suture.
  • An electric motor to provide power to the pump impeller is indicated at 16 and contains motor windings and laminations 60, and a housing 62 with an electric cable 68.
  • FIG. 4 illustrates the housing containing the windings and laminations of the motor for use in an embodiment such as shown in FIG. 2 where the motor and housing are reusable and the other complements of the cannula pump are disposable.
  • the motor and housing in FIG. 4 combine with the disposable pump and bearings illustrated in FIG. 5 and an outflow cannula portion to yield the complete operational device shown in FIG. 2.
  • FIG. 3 the general layout of an axial flow pump such as may be used with many embodiments of the invention is shown.
  • Several axial flow pump impeller blades 38 are mounted on an impeller hub 36 supported for rotation on a set of bearings 40, 42 and 44.
  • the impeller is driven by a stiff rotating wire 34 which transmits rotary mechanical energy produced by the electric motor to the impeller.
  • the impeller hub rotating thrust bearing member 40 and shaft 34 are all bonded together to form a single rotating unit.
  • Shaft 34 extends into stationary bearing 42 and is rotationally supported by it.
  • Shaft 34 also passes through stationary bearing element 44 and is rotationally supported by that bearing member.
  • Rotating thrust bearing member 40 is composed of a wear-resistant material similar to the stationary bearing elements 42 and 44.
  • the rotating impeller is supported by the bearing elements in such a fashion that there is a smooth, continuous line of flow across the junction between the stationary and rotating components of the pump at gaps 54 and 56.
  • the blood enters the inflow side holes 22, passes across the inflow stator blades 52, supported on the inflow hub 47, smoothly crosses the gap between the inflow hub and the impeller hub at 54, passes across the impeller blades 38 and the impeller hub 36, and then smoothly passes across the gap 56 between the rotating impeller hub and outflow stator hub 46 and finally passes across the outflow stator blades 48 and then out of the pump through the outflow cannula.
  • FIG. 5 shows the disposable cannula pump including the axial flow pump bearings, drive shaft, and the motor magnet and motor magnet bearings utilized to transmit torque magnetically from the windings of the motor to the shaft.
  • the elongated outflow cannula segment is omitted in FIG. 5.
  • a slot 66 in the disposable portion of the cannula pump is configured to receive a pin 64 (FIG. 4) as the motor is coupled to the cannula.
  • this coupling is accomplished by sliding the disposable cannula components shown in FIG. 5 into the motor housing shown in FIG. 4 which results in the assembly shown in FIG. 2.
  • the pin and slot prevent the cannula from rotating within the motor housing thereby permitting the rotational torque to turn only the motor magnet and attached elements and not rotate the entire cannula.
  • the disposable components are retained in proper connection to the reusable motor and housing components by magnetic forces, by an interference fit, or by other mechanical means.
  • the motor magnet 70 Power to rotate the impeller is transmitted to the shaft 34 by the magnet 70 which is bonded to the shaft 34 via an intermediary hollow shaft 76.
  • the motor magnet is caused to rotate by the rotating electromagnetic fields produced by the surrounding motor windings (60 in FIG. 2) and thus it is seen that in the embodiment shown in FIG. 5 the entire end of the disposable portion of the cannula pump containing the motor magnet may be sealed and thus eliminate rotary mechanical shaft seals through which either air or fluids could leak.
  • the motor magnet 70 is supported by a pair of bearings 72 and 74 via the shaft 76. These bearings may be any of a number of suitable types, including fluid-lubricated sleeve-type journal bearings, ball bearings, or hydrodynamic fluid film bearings.
  • the motor magnet bearings 72 and 74 are located some distance from the pump impeller bearings 42 and 44.
  • the drive shaft 34 transverses an elongated channel 58, and any blood which enters this chamber through the narrow gap between the shaft 34 and the impeller bearing 44 must travel the full length of this channel to reach the motor magnet bearings.
  • a elastomeric flexible sealing stopper 82 is inserted into a hole in the end of the cannula near the motor magnet bearings.
  • This stopper may be punctured by a small hypodermic needle 84 through which fluid can be injected into the chamber containing the motor magnet and motor magnet bearings which is in continuity with the chamber leading to the impeller bearing 44.
  • an appropriate fluid such as sterile heparinized saline or a low-molecular-weight dextran solution is injected via hypodermic needle 84 so as to completely fill the chamber surrounding the motor magnet, motor magnet bearings, and shaft. Air that is present in this chamber at the time the fluid is ejected is forced to exit in the vicinity of the impeller through the narrow gap between the shaft 34 and the bearing sleeve 44.
  • a small hole 78 may be included to facilitate passage of the fluid through the bearings while the chamber is being filled.
  • the hypodermic needle is withdrawn and the stopper 82 seals the needle hole.
  • blood fills the outflow section of the cannula and the space surrounding the impeller and inflow and outflow stator blades and a tiny amount of blood enters the gap between the rotating impeller hub and stationary stator hubs.
  • a film of blood diffuses into the gap between the stationary impeller bearings 42 and 44 and the rotating shaft 34. This blood mixes with the anticoagulated fluid in the gap between bearing sleeve 44 and shaft 34 and thus when the pump is turned on the bearing is immersed in blood partly diluted by the anticoagulated fluid.
  • FIG. 6 shows an embodiment of the invention in which the electric motor as well as the remainder of the cannula pump are all integrated in one disposable unit.
  • Disposable motor 92 is enclosed in a polymeric housing 86 which is attached to the axial flow pump section 18 at the inflow stator blade supports 88.
  • the embodiment shown in FIG. 6 functions very similarly to the embodiment shown in FIG. 2 and has the advantage that the air gap 94 between the motor windings 92 and the motor magnet 90 can be very small permitting high efficiency of the motor. As seen in FIG. 2, the air gap 96 must be larger when the motor is separable from the cannula parts of the pump to accommodate the cannula wall.
  • anticoagulated fluid may be injected via the hypodermic needle into chamber 80 which communicates with the elongated chamber 58 via the bore of the motor. Fluid thus can be injected via the hypodermic needle and completely fill the chambers containing the motor, motor bearings, and shaft, and reach the blood contacting portion of the pump at the impeller bearing 44.
  • FIG. 7 shows an additional embodiment of the invention in which the motor may be reusable and provided in a sterilizable housing which may be attached to a disposable portion of the catheter pump containing the stators, impeller, and inflow and outflow openings for the blood.
  • the motor 98 is encased in a motor housing 100 and incorporates ball bearings 104 and 106 supporting a shaft 108 fixed to the motor magnet 102.
  • the shaft is sealed with a radial lip seal 110.
  • the shaft has a cavity 114 which is not round in cross section but another shape such as square or rectangular and is adapted to receive a like-shaped shaft extension 112 which provides a coupling to transmit rotary torque from the motor shaft 108 to the cannula pump shaft 34.
  • the motor bearings and motor magnets are not surrounded by fluid but rather are surrounded by air. Blood and other fluids are kept out of the chamber in which the motor is housed by the rotary shaft seal 110. Similarly, chamber 58 in the disposable part of the device may remain filled with air rather than fluid because two rotary shaft seals 122 and 124 are utilized to exclude fluids.
  • the cannula portion is affixed to the motor portion by inserting the shaft 112 into the hole 114 and pressing the end of the cannula 118 into the hole 120 in the end of the motor housing.
  • the parts may be thus attached together by an interference friction fit or other methods of retention may be provided, such as a screw-on connector.
  • the function of the blood pump impeller, stators, and pump impeller bearings is very similar to that described for the embodiment shown in FIG. 3, with the bearings immersed in blood which enters the narrow gaps between the rotating and stationary parts.
  • FIG. 8 illustrates a cannula pump in which a motor 126 is utilized which is of small enough diameter to be inserted through a small incision in the heart., such as in the apex.
  • a motor approximately 12 mm in diameter by 22 mm long, provides sufficient power to pump the entire normal workload of the left ventricle, and sufficiently powerful motors can be made even smaller.
  • the motor receives electric power through wires 156 which enter the heart via a cable 158 which passes across the wall of the ventricle and is sealed by a purse string suture 28 or may pass across the wall of the heart at another location.
  • the rotor of the motor 128 is supported by bearings 130 and 132 and is connected to the pump impeller hub 134 which supports the impeller blades 136 by a small diameter shaft 133.
  • a rotary shaft seal 142 prevents blood from entering the motor and motor bearing housing 127.
  • Additional blood immersed bearings, 138 and 140 are provided to support the shaft within the blood stream.
  • Bearing 138 is supported in the motor housing and bearing 140 is supported by the hub of the outflow stator 136 which in turn is supported by outflow stator blades 137 within the pump housing 148.
  • FIG. 9 shows a cannula pump inserted into the left ventricle 2 at the apex and retained in place temporarily by a purse string suture 128.
  • the power cable 158 protrudes from the apex and connects to the motor controller and electric power source (not shown). This embodiment is advantageous compared to that shown in FIG. 1 in which the motor located outside the heart can interfere with the surgeon's other tasks, such as suturing coronary artery bypass grafts.
  • FIG. 10 shows another embodiment in which the device is inserted across the wall of the right atrium and affixed in place by a purse string suture 29.
  • the device utilizes a motor 160 which is within the right atrium 164, connected to the pump impeller, 168 by a flexible shaft 166 and also a small diameter rigid shaft 135. This shaft is supported on blood immersed bearings (not shown) in a fashion similar to the pump of FIG. 8.
  • the pump is enclosed in a pump housing 170 which is located in the left ventricle and the blood is pumped across an outflow cannula through the aortic valve 24 and is discharged into the aorta at 172.
  • This separation of the motor and pump has the advantage that there is a long distance for blood to diffuse from the pump to the motor for embodiments that do not use a rotary shaft seal.
  • an embodiment similar to that shown in FIG. 10 can be applied with the motor in the left atrium and the pump in the left ventricle.
  • FIG. 11 shows another embodiment similar to that shown in FIG. 8 in which the pump housing 148 is elongated sufficiently to permit the pump 136 to be in the aorta while the motor 126 is in the ventricle.
  • the rotating shaft 133 transmits power across the aortic valve 24 to the pump impeller.
  • cannula pump invention includes embodiments in which the cannula pump is provided with two separate flexible polymeric tubular extensions to permit insertion of one as an inflow and the other as an outflow tube.
  • numerous other useful embodiments may be provided.
US08/015,246 1992-10-30 1993-02-05 Cannula pumps for temporary cardiac support and methods of their application and use Expired - Lifetime US5376114A (en)

Priority Applications (11)

Application Number Priority Date Filing Date Title
US08/015,246 US5376114A (en) 1992-10-30 1993-02-05 Cannula pumps for temporary cardiac support and methods of their application and use
AU53635/94A AU678411B2 (en) 1992-10-30 1993-10-18 Cannula pumps for temporary cardiac support
CA002147616A CA2147616C (fr) 1992-10-30 1993-10-18 Pompes a canule pour assistance cardiaque temporaire
JP6511123A JPH08504621A (ja) 1992-10-30 1993-10-18 一時心臓支援用カニューレポンプ
EP93923927A EP0746344A4 (fr) 1992-10-30 1993-10-18 Pompes a canule pour assistance cardiaque temporaire
PCT/US1993/009947 WO1994009835A1 (fr) 1992-10-30 1993-10-18 Pompes a canule pour assistance cardiaque temporaire
US08/325,848 US5776190A (en) 1992-10-30 1994-10-19 Cannula pumps for temporary cardiac support and methods of their application and use
US08/334,498 US5755784A (en) 1992-10-30 1994-11-04 Cannula pumps for temporary cardiac support and methods of their application and use
AU17703/95A AU683994B2 (en) 1992-10-30 1995-04-28 Cannula pumps for temporary cardiac support
AU17704/95A AU678697B2 (en) 1992-10-30 1995-04-28 Cannula pumps for temporary cardiac support
US08/974,019 US5888241A (en) 1992-10-30 1997-11-19 Cannula pumps for temporary cardiac support and methods of their application and use

Applications Claiming Priority (2)

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US96903492A 1992-10-30 1992-10-30
US08/015,246 US5376114A (en) 1992-10-30 1993-02-05 Cannula pumps for temporary cardiac support and methods of their application and use

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US96903492A Continuation-In-Part 1992-10-30 1992-10-30

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US08/325,848 Division US5776190A (en) 1992-10-30 1994-10-19 Cannula pumps for temporary cardiac support and methods of their application and use
US08/334,498 Continuation US5755784A (en) 1992-10-30 1994-11-04 Cannula pumps for temporary cardiac support and methods of their application and use

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US5376114A true US5376114A (en) 1994-12-27

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US08/015,246 Expired - Lifetime US5376114A (en) 1992-10-30 1993-02-05 Cannula pumps for temporary cardiac support and methods of their application and use
US08/325,848 Expired - Lifetime US5776190A (en) 1992-10-30 1994-10-19 Cannula pumps for temporary cardiac support and methods of their application and use
US08/334,498 Expired - Lifetime US5755784A (en) 1992-10-30 1994-11-04 Cannula pumps for temporary cardiac support and methods of their application and use
US08/974,019 Expired - Lifetime US5888241A (en) 1992-10-30 1997-11-19 Cannula pumps for temporary cardiac support and methods of their application and use

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US08/325,848 Expired - Lifetime US5776190A (en) 1992-10-30 1994-10-19 Cannula pumps for temporary cardiac support and methods of their application and use
US08/334,498 Expired - Lifetime US5755784A (en) 1992-10-30 1994-11-04 Cannula pumps for temporary cardiac support and methods of their application and use
US08/974,019 Expired - Lifetime US5888241A (en) 1992-10-30 1997-11-19 Cannula pumps for temporary cardiac support and methods of their application and use

Country Status (6)

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US (4) US5376114A (fr)
EP (1) EP0746344A4 (fr)
JP (1) JPH08504621A (fr)
AU (3) AU678411B2 (fr)
CA (1) CA2147616C (fr)
WO (1) WO1994009835A1 (fr)

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AU683994B2 (en) 1997-11-27
US5755784A (en) 1998-05-26
JPH08504621A (ja) 1996-05-21
EP0746344A4 (fr) 1997-12-03
EP0746344A1 (fr) 1996-12-11
US5888241A (en) 1999-03-30
CA2147616A1 (fr) 1994-05-11
AU678697B2 (en) 1997-06-05
US5776190A (en) 1998-07-07
CA2147616C (fr) 2004-01-20
AU678411B2 (en) 1997-05-29
AU1770495A (en) 1995-06-29
AU1770395A (en) 1995-06-29
AU5363594A (en) 1994-05-24
WO1994009835A1 (fr) 1994-05-11

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